FDA Puts Eganelisib on Fast Track for Advanced Triple-negative Breast Cancer




The U.S. Food and Drug Administration has granted fast track status to immuno-oncology candidate eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy as a first-line treatment for patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).

Fast track designation speeds clinical development, regulatory review, and marketing approval of potential medications for serious medical conditions with unmet needs.

The FDA previously granted fast track status to eganelisib, which is being developed by Infinity Pharmaceuticals, in combination with the checkpoint inhibitor Opdivo (nivolumab) as a treatment for advanced urothelial cancer.

“Fast Track designation is an exciting regulatory milestone that bolsters our momentum in TNBC,” said Adelene Perkins, Infinity’s CEO, in a press release.

Eganelisib is an oral, once-daily selective inhibitor of phosphoinositide-3-kinase gamma (PI3K-gamma). Evidence from past studies indicates that tumor cells use PI3K-gamma to overcome mechanisms that would otherwise prevent the out-of-control cell growth characteristic of metastatic cancers.

The company is currently enrolling patients into a Phase 2 study called MARIO-3 (NCT03961698) across 21 locations in the United States. More information is available here.

In collaboration with Roche/Genentech, the study will test the addition of eganelisib in combination with Tecentriq (atezolizumab) and Abraxane (albumin-bound paclitaxel) to standard care among approximately 60 patients: 30 with programmed death-ligand 1 positive disease and 30 without.

The study’s main goal is to assess the complete response rate — the absence of any detectable cancer — as measured by the Response Evaluation Criteria in Solid Tumors v1.1 over 12 months.

Secondary goals include objective response rate (the proportion of patients with a predefined tumor reduction in a minimum time period), time to complete remission, time to response, complete response duration, response duration, and progression-free survival.

A separate cohort in the same study consists of patients with renal cell cancer receiving eganelisib with Tecentriq and Avastin (bevacizumab).

“TNBC remains the deadliest form of breast cancer, and there is tremendous need to expedite the development of new treatments that have the potential to improve outcomes in these patients,” Perkins said.

“We … are particularly encouraged by the early signals of clinical activity we have seen in MARIO-3 to date,” she added. “We look forward to presenting these important data later this year.”

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